• Global synergies between clinical, HEOR and RWE data
• Evidence required to achieve adequate device price and market access in US
• Successful evidence strategies for medical devices vs. pharma
Maria Koullick Sr. Director Global Reimbursement and Health Care Economics Abbott
• Public and private agencies using HTA reports
• Factors shaping private and public sector HTA programs
• Effectiveness of DERP (drug effectiveness review project)
• Affordability and infrastructure changes
• Healthcare reform increasing broader patient access
• Defining biopharmaceuitical brand value in emerging versus developed economies
Kris Thiruvillakkat Global Market Access Strategist Pfizer
• Review the development and trends of biologic and biosimilar in EU and US from payer’s perspective
• Different opportunities and challenges of biologics vs biosimilar and chemical brands vs generics
• Review the evidence needs and role of HEOR in the development of biologics and biosimilar
• Essential market access strategies to ensure appropriate use
Boxiong Tang Senior Director GHEOR TEVA
• Defining the terminology, agreeing with the approach, and cross-functional working within a pharmaceutical company
• Actively learning about changes in stakeholder’s needs
Martin Rost Senior Director Global Market Access Team Lead Pfizer
• HEOR in rare and orphan disease
• Incerasing HTA and payer outcomes and economic evidence requirements
• Potential paths forward
Phil Sarocco Head HEOR Shire
• Capture basic metrics needed to optimize value
• Place the patient at the heart of decision-making
• Track emerging evidence to ensure developemtn evolves with the landscape
Amanda Bruno Senior Director, Value Evidence Leader, Oncology, Dermatology, & Infectious Disease GSK
• How to improve long term profitability
• Developing different pricing models
• What drives the value of the product in the real-world evidence in terms of outcome and impact
• Value-based contracting and outcomes-based arrangements
• Discounted pharmaceutical pricing
• Increasing shortage of competencies
• Improved patient access & RWE
Tony Hebden Vice President HEOR AbbVie
• Coverage with Evidence Development
• HTA and Clinical Practice Guidelines
• Cost-Effectiveness Thresholds, Comparative Effectiveness Programs
• What lies ahead?
Maria Koullick Sr. Director Global Reimbursement and Health Care Economics Abbott, Phil Sarocco Head HEOR Shire
• Understand key price drivers within and across the U.S.
• Shift from a pay-for-pill to a pay-for-performance model
• Recognize trends in the industry, capitalize on the opportunities, and overcome the challenges
• Identifying value from the point of view of different stakeholders
• Providing clinical and RWE to support claims of value from payer perspective
• Translating clinical evidence into economic value to payers
Ali Samiian Director, Global Market Access & HEOR Abbott
• Rising Control & Cost Share for Access
• Impact of biosimilars in specialty drugs
• Need for risk-sharing
• What does the future bring?
• Policy advocacy has been pivotal to the quality and safety of advanced diagnostic imagins
• In recent years major gaps have emerged in how providers maintain imaging equipment: (a) providers had few rules on the frequency of preventative maintenance, and (b) servicers faced unequal FDA regulation of maintenance
• A coalition of stakeholders has engaged with policymakers to close these gaps, resulting in changes to guidance for frequency of preventative maintenance from the Centers for Medicare and Medicaid Services and The Joint Commission, opening of a docket and a public workshop on the regulation of service at the Food and Drug Administration and a requirement in the 2017 FDA Reauthorization Act for the FDA to produce a report on the regulation of equipment service
Jonathan Brenner Senior Director Market Access, Radiology Bayer
• U.S. diverse multi-payer system
• Reimportation
• Value Proposition & Value Dossier to the R&D
• How will patients respond to a product when it enters the market?
• Observational studies and pragmatic clinical trials (PCT) in HER
• Real-world Intelligence
• Industry should transition from being a transactional supplier of medicines to an integrated collaborative partner within the healthcare system
• Value-based partnerships are mutually beneficial endeavors to deliver the highest value to the healthcare system and society by focusing on improving patient outcomes in the context of system and societal total costs
• Value-based partnerships can range from research-oriented collaborations to commercially-oriented arrangements
Jason Spangler Executive Director, Value, Quality, & Medical Policy Amgen
• Unlocking data from early access
• Effective communications with your internal and external stakeholders
• Embracing the digital vision
• Intellectual property rights (IPR)
• Ever-greening strategy
• What’s the rationale for a product’s price point?
• The implications of Trans-Pacific Partnership (TPP) Agreement
• Affordable Care Act
• Digital pharma
• Patient centricity
• Collaborations, mergers and acquisitions